Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

This study has been completed.

Sponsor:

Bayer

ClinicalTrials.gov Identifier:

NCT00562913

First Posted: November 26, 2007

Last Update Posted: November 26, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in Patients With Advanced, Refractory Solid Tumors

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

At least 18 years old

Advanced histological or cytological documentation of cancer

life-expectancy of at least 12 weeks

able to swallow pills

ECOG status of 0,1 or 2

adequate bone marrow

liver and renal function

Exclusion Criteria:

> NYHA Class 2 CHF

Serious myocardial dysfunction,

or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)

History of organ allograft

uncontrolled hypertension

renal dialysis

Bleeding event/hemorrhage within 4 weeks of study treatment

major surgery within 4 weeks of study treatment

Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562913